Low profile EVAR devices show encouraging results

1st February 2012

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“Despite advancements in stent graft technology, there is still room for improvement with current EVAR devices,” said Giovanni Torsello, St Franziskus-Hospital Munster, Germany, during the presentation of the INNOVATION study results at the LINC conference in Leipzig, Germany. INNOVATION is a study which investigates the Incraft device from Cordis. Torsello told attendees that the initial experience, one-month results and preliminary longer-term follow-up with the new customisable, ultra-low profile Incraft stent graft are encouraging and further studies are underway in Europe and the USA. The device is not approved in any market.

In a live case transmission in the same session, Andrej Schmidt, from the Leipzig Heart Centre, performed percutaneous repair of an abdominal aortic aneurysm with an Ovation device (TriVascular). The live case was followed by a presentation by Dierk Scheinert, Leipzig, Germany, on the one-year data from the Ovation European prospective multicentre study.

Scheinert told delegates that there were no major adverse events at 30 days for any of the 30 patients treated with the device. “At three years, there were no device related major adverse events,” he added. In terms of device performance, Ovation also showed 100% technical success, and freedom from endoleaks (types I, III and IV), migration, rupture and conversion to open repair at 30 days and three years.

In a voting during the session, 84% of the delegates voted Yes for the question on whether low profile abdominal aortic aneurysm devices will have a widespread use in the future. Ten per cent said low profile device will be used only with small access vessels and 6% said they were concerned about long-term durability and adverse events.